Medical pump electronic pairing with device

ABSTRACT

Systems and methods for wireless electronic communication between a medical apparatus and a remote electronic computing device comprise generating and outputting by the medical apparatus an output signal, including: encoding data in the output signal according to a predetermined characteristic of the output signal; receiving and decoding by the remote electronic computing device the encoded data in the output signal; and establishing a pairing between the medical apparatus and the remote electronic computing device.

RELATED APPLICATIONS

This application claims priority under 35 U.S.C. section 119(e) fromU.S. Provisional Patent Application No. 62/971,789, filed Feb. 7, 2020,by Hugh Molesworth, et al., and entitled “Pump to Device DataManagement”, and from U.S. Provisional Patent Application No.62/971,807, filed Feb. 7, 2020, by Hugh Molesworth, et al., and entitled“Pump to Device Pairing,” the content of each of which is herebyincorporated by reference in its entirety.

BACKGROUND

Modern medical devices such as syringe or peristaltic-type pumps orother medical infusion devices typically require a user interface suchas a display screen, buttons, activation switches, or other input/outputdevices to operate and control the pumps. With the emergence ofimprovements in computer technology, a need exists for a system toprovide remote monitoring and control of medical pumps or the like. Thedelivery of therapeutic and non-therapeutic medical fluids is commonlyperformed intravenously (IV) or subcutaneously using a catheter orcannula and a syringe pump. However, a diabetic patient wearing aninsulin delivery pump may require a remote practitioner such as a doctoror nurse to monitor and control the delivery of insulin to the patientand further may benefit from convenient, wireless monitoring and controlof their own medical device.

SUMMARY

In one aspect, a method for wireless electronic communication between amedical apparatus and a remote electronic computing device comprisesgenerating and outputting by the medical apparatus an output signal,including: encoding data in the output signal according to apredetermined characteristic of the output signal; receiving anddecoding by the remote electronic computing device the encoded data inthe output signal; and establishing a pairing between the medicalapparatus and the remote electronic computing device.

In some embodiments, the medical apparatus includes an insulin deliverypump or other medical device and the remote electronic computing deviceincludes a user interface and an input/output computing element foroperating and controlling the insulin delivery pump or other medicaldevice.

In some embodiments, the wireless electronic communication complies withat least one of a Bluetooth Low Energy (BLE) wireless protocol, a nearfield communication (NFC) protocol, or a radio-frequency identification(RFID) protocol.

In some embodiments, the predetermined characteristic of the outputsignal includes a bit rate or a symbol transmission rate, and the outputsignal includes data encoded according to the bit rate or a symboltransmission rate.

In some embodiments, the method further comprises varying the bit ratein a sequence that generates the code, wherein the varied bit ratecreates a pattern that is recognized by the remote electronic computingdevice and identified to represent a unique identification that isacceptable for pairing.

In some embodiments, the bit rate or the symbol transmission rate isprocessed for encoding the data instead of data in a plurality ofadvertising packets exchanged between the remote electronic computingdevice and the medical apparatus by the medical apparatus including aprocessor and a memory that executes and stores, respectively, a customBluetooth Low Energy (BLE) stack including a unique profile that matchesa profile stored on the remote electronic computing device.

In some embodiments, the predetermined characteristic of the outputsignal includes a signal strength of the output signal, and the outputsignal includes data encoded according to a modulated received signalstrength indicator (RSSI) that is output to the remote electroniccomputer device.

In some embodiments, the method further comprises configuring themedical apparatus to include an electronic pairing device that processesan external event that changes a current state of the medical apparatusto a state that initiates the pairing.

In another aspect, a method for wireless electronic communicationbetween a medical apparatus and a remote electronic computing device,comprises configuring the medical apparatus to include an electronicpairing device; receiving by the electronic pairing device an externalevent that changes a current state of the medical apparatus to a statethat authorizes a secure pairing and authentication operation with aremote electronic computing device; and outputting by the medicalapparatus a signal that facilitates the secure pairing andauthentication operation with the remote electronic computing device.

In some embodiments, the electronic pairing device of the medicalapparatus includes a near field communication (NFC) device and themethod further comprises executing the NFC device to share data with theremote electronic computer device, wherein the data is secure due theNFC device exchanging an encryption key with the near fieldcommunication (NFC) device.

In some embodiments, the method further comprises forming a couplingbetween the medical apparatus and the remote electronic computer device;and modulating signals on a mutual capacitance, wherein the remoteelectronic computer device receives an AC coupled version of voltagepulses generated at the medical apparatus, which are decoded into thedata.

In some embodiments, the electronic pairing device of the medicalapparatus includes a voice recognition sensor that receives as theexternal event voice sounds captured by the remote electronic computerdevice, wherein the method further comprises converting the capturedvoice sounds into electronic signals for output to the medicalapparatus; and instructing the medical apparatus via voice commands toaccept a pairing request from the mobile device.

In some embodiments, at least one of the electronic pairing device ofthe medical or the remote electronic computer device employs an audibleemission that includes encoded data.

In some embodiments, each of the electronic pairing device and theremote electronic computer device includes an inertial measurement unitthat detects a force when the medical apparatus in communication withthe remote electronic computer device and detected signals in eachinertial measurement unit match to confirm a pairing with respect to apairing attempt of at least one of the pairing and authenticationoperation.

In some embodiments, at least one of the electronic pairing deviceincludes at least one light emitting device such as an LED or the likeand one or more sensors of electromagnetic radiation of the at least onelight emitting device that facilitates at least one of the pairing andauthentication operation.

In another aspect, a medical apparatus comprises a controller thatencodes data in an output signal according to a predeterminedcharacteristic of the output signal and establishes a pairing with aremote electronic computing device including the encoded data in theoutput signal; and an electronic pairing device that receives anexternal event for changing a current state of the medical apparatus toa state that authorizes a secure pairing and authentication operationwith the remote electronic computing device.

In some embodiments, at least one of the electronic pairing deviceincludes an inertial measurement unit that that detects a force in themedical apparatus that when detected triggers a pairing attempt of theat least one pairing and authentication.

In some embodiments, when coupled together at least one of theelectronic pairing device detects an orientation of the medicalapparatus and/or the remote electronic computer device, and that recordsa change in the orientation to generate an encryption key for at leastone of the pairing and authentication.

In some embodiments, at least one of the electronic pairing device ofthe apparatus and an inertial measurement device of the remoteelectronic computing device detects a tactile force of a coupling of themedical apparatus fand remote electronic computing device for purposesof at least one of pairing and authentication. The tactile force can bea shake, tap, squeeze, or other physical interaction with the medicalapparatus.

In another aspect, a medical apparatus comprises a controller thatencodes data in an output signal according to a predeterminedcharacteristic of the output signal and establishes a pairing with aremote electronic computing device including the encoded data in theoutput signal; and an electronic pairing device that receives anexternal event for changing a current state of the medical apparatus toa state that authorizes a secure pairing and authentication operationwith the remote electronic computing device.

Certain embodiments are described further in the following description,examples, claims and drawings. These features of embodiments will becomemore apparent from the following detailed description when taken inconjunction with the accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the invention and its embodiment are betterunderstood by referring to the following detailed description. Tounderstand the invention, the detailed description should be read inconjunction with the drawings, in which:

FIG. 1 is a schematic depiction of a medical pump system, in accordancewith some embodiments.

FIG. 2 is a block diagram of the medical pump system of FIG. 1 ,including components of a medical pump and mobile electronic device ofthe system and a communication exchange therebetween, in accordance withsome embodiments.

FIG. 3 is a flow diagram of an embodiment of a method for data hiding ina pairing exchange between a medical pump and mobile electronic device,in accordance with some embodiments.

FIG. 4 is a block diagram of a medical pump system including componentsof a medical pump and mobile electronic device of the system and acommunication exchange therebetween, in accordance with otherembodiments.

FIG. 5 is a flow diagram of an embodiment of a method for data hiding ina pairing exchange between the medical pump and mobile electronic deviceof the medical pump system of FIGS. 1 and 4 , in accordance with someembodiments.

FIG. 6 is a block diagram of a medical pump system employing acapacitive, inductive, or otherwise near field communication (NFC)system as part of a pairing operation, in accordance with otherembodiments.

FIG. 7 is a block diagram of a medical pump system employing voicerecognition as part of a pairing operation, in accordance with otherembodiments.

FIG. 8 is a block diagram of a medical pump system employing acousticcommunications as part of a pairing operation, in accordance with otherembodiments.

FIG. 9 is a block diagram of a medical pump system employing gravitysensing devices as part of a pairing operation, in accordance with otherembodiments.

FIG. 10 is a block diagram of a medical pump system employing lightsensors as part of a pairing operation, in accordance with otherembodiments.

FIG. 11 is a block diagram of a medical pump system, in accordance withother embodiments.

FIG. 12 is a block diagram of a medical pump system employing aninertial measurement unit as part of a pairing operation, in accordancewith other embodiments.

FIG. 13 is a block diagram of a medical pump system employing anatmospheric pressure sensor as part of a pairing operation, inaccordance with other embodiments.

The drawings are intended to illustrate certain exemplary embodimentsand are not limiting. For clarity and ease of illustration, the drawingsmay not be made to scale, and in some instances, various aspects may beshown exaggerated or enlarged to facilitate an understanding ofparticular embodiments.

DETAILED DESCRIPTION

A wireless communication medium is required for a data exchange betweena medical device and a remote electronic device, such as a user'ssmartphone, a custom or third party controller, continuous glucosemonitor, and so on. Examples of a medical device may include medicalpump embodiments and their associated methods and accessories to whichthe suitable devices and methods discussed herein may be applied mayinclude those discussed in commonly owned U.S. patent application Ser.No. 15/122,132, filed Aug. 26, 2016, by P. DiPerna, titled “FluidDelivery Pump,” U.S. Pat. No. 16,028,256, filed Jul. 5, 2018, by P.DiPerna et al., titled “Medical Pump with Flow Control,” U.S. patentapplication Ser. No. 16/520,521, filed Jul. 24, 2019, by P. DiPerna etal., titled “Subcutaneous Access Hub with Multiple Cannula Ports,” U.S.patent application Ser. No. 15/122,132, Publication No. US 2016/0361489A1, filed Mar. 3, 2015, by P. DiPerna, titled “Fluid Delivery Pump”, andU.S. patent application Ser. No. 17/111,402, filed Dec. 3, 2020, andtitled “Training Cartridge for Medical Pump Systems,” each of which isincorporated by reference herein in its entirety.

In some embodiments, the wireless electronic communication mediumcomplies with the Bluetooth™ Low Energy (BLE) wireless protocol areanetwork technology, but is not limited thereto. Regardless of wirelesscommunication medium, it is desirable for a medical apparatus such as aninsulin pump to be connected to a remote electronic device, e.g., asmartphone, medical device controller, or the like, in a secure mannerto allow useful and safe data transfer for patient privacy and securecontrol of the pump. Forming such a network connection in a safe andsecure manner by a wireless electronic communication process commonlyknown as “pairing” permits the pump and remote electronic device toexchange data, for example, data including results collected by thepump.

Broadly speaking, wireless pairing occurs in a variety of ways. By wayof example, BLE technology has three pairing options: Passkey Entry,Just Works, and Out-of-Band (“OOB”).

Passkey Entry requires that the user enters data to securely pair, whichmay be of little use to patients with no access terminal or anyunderstanding of the pairing process with no means for patient dataentry and no display. Just Works™ pairing or the like has limitedsecurity and is therefore probably not an option for use with the pump.The third option, Out-of-Band pairing (OOB), represents the most secureoption by completing the pairing process and encryption key exchangeentirely out of band. This may take place in any method aside from theprimary communication channel. Desirable characteristics of this optionmay include minimizing the potential for third parties to eavesdrop onthe encryption key transfer and ensuring that only authorized devicescan initiate the pairing process. Regardless of pairing options, since apump employing BLE transmits or “advertises” identity information, it isimportant to ensure that this information is secure and safe frommalicious access.

In brief overview, embodiments of the present inventive conceptsincorporate one or more techniques for data hiding, secure pairing,and/or authentication, while complying with a wireless communicationprotocol such as BLE.

Referring generally to FIG. 1 , a medical pump system is shown thatincludes a medical apparatus, for example, a pump 10, and a remotemobile device 12, such as a user's smartphone, a custom or third partycontroller, continuous glucose monitor, or the like configured towirelessly exchange data with each other in a secure manner. It shouldbe noted that in many cases, the embodiments of the pump 10 discussedherein may be operated directly by medical professionals that aretreating patients. In many cases, the medical apparatus embodimentsdiscussed herein may also be operated directly by individual end usersthat suffer from a particular medical condition, such as diabetes. Suchindividual end users may be using such pump embodiments to administernon-therapeutic fluids or therapeutic fluids such as saline,antibiotics, dextrose solutions, pain medications, peptides, and thelike. Some therapeutic fluids that may be delivered by the medical pumpsystem embodiments discussed herein may include therapeutic fluids usedfor the treatment of diabetes as well as other related medicalconditions.

The remote mobile device 12 may include a processor and memory forexecuting and storing a software application that exchanges data withthe medical pump 10, and includes a user interface that displays datareceived from the medical pump 10 and permits a user to enterinformation for output to the pump 10. For example, the pump 10 mayinclude a patient port 102 or the like for exchanging fluids with apatient's body. Information regarding a fluid communication may beexchanged with the remote mobile device 12. For example, the remotemobile device 12 can output command data to the pump 10 to control anamount of insulin to be output via the patient port 102 into thepatient's body. In another example, the remote mobile device 12 mayreceive temperature, blood pressure, or other medical informationcollected from sensors of the pump 10.

Prior to a data exchange between the pump 10 and remote mobile device12, the pump 10 and remote mobile device 12 must be wirelessly paired.In wirelessly pairing the mobile device 12 and the pump 10, Bluetooth™or other wireless technology is executed by the pump 10 and mobiledevice 12 that includes the transmission of advertising packets thatinclude information that allow other devices to connect, but can alsoprovide information about a device, such as data collected by the pump10.

In some embodiments, as shown in FIG. 2 , the pump 10 includes acontroller 20. The controller 20 may include a computer processor 16such as a microprocessor and memory 18 as well as any suitablecomponents that may be useful for interfacing with various elements ofthe pump 10. Such components may include electrical contacts, electricalconduits such as wiring, as well as drivers and any other instructionsstored in the memory 18 that may facilitate use of the medical pump 10.This allows the controller 20 to monitor ambient temperature, ambientatmospheric pressure, and other information that may be of interest to auser of the mobile device 12.

In establishing a pairing between a medical pump and a remote mobiledevice such as a smartphone, keys are established which can then be usedto encrypt a link, verify signed data, or perform other authenticationfunctions. As shown by flow arrow 202, the pump 10 outputs (202) one ormore advertising packets generated by the advertising packet generator24 for response by the mobile device 12. The advertisement packets aretransmitted and typically encoded to provide a level of security withrespect to communication between the pump 10 and the mobile device 12.When the mobile device 12 responds (204), a handshake (bonding) isformed (206), facilitating a confirmed transfer (208) of data to themobile device 12. The mobile device 12 can in turn display the data,output the data to another device, such as a cloud computingenvironment, remote database, or perform other operations on thereceived data.

Also stored in the memory 18 and executed by the processor 16 of thecontroller 20 may include a special-purpose encoder 22 and anadvertising packet generator 24. As described herein, the encoder 22executes a different encoding means such as bit rate than the datacontained in the advertising packet. Accordingly, the encoder 22includes a data hiding processor 23 for encoding symbols, etc. in aparticular manner according to the bit rate at which an advertisingpacket is transmitted at step 202. The data hiding processor 23 may be atype of electronic pairing device that is implemented in hardware,software, firmware, or a combination thereof. The mobile device 12includes a special-purpose decoder 32 at step 204 is constructed andarranged to receive and decode the advertising packets from the pump'sencoder 22.

In some embodiments, in addition to transmitting and encodingadvertising packets, the controller 20 can vary the bit rate in asequence that generates the code. Therefore, the actual packets ofencrypted data are not required as the critical component of providingsecurity but rather the process of delivering in a varied bit rate whichcreates a pattern that can be recognized by the connecting device 12 andidentified to represent a unique identification (ID) that is acceptablefor pairing.

FIG. 3 is a flow diagram of an embodiment of a method 300 for datahiding in a pairing between the medical pump 10 and mobile electronicdevice 12 of the medical pump system of FIGS. 1 and 2 , in accordancewith some embodiments. At least some of method 300 can be executed by anelectronic pairing device of the controller 20 that is implemented inhardware, software, firmware, or a combination thereof.

At block 302, the pump 10 employs an encoding scheme to the advertisingpackets formed by the advertising packet generator 24. For someembodiments, the controller microprocessor 16 may include a low powerconsuming high performance microprocessor that executes code accordingto BLE, near field communication, and the like.

As is well-known, an advertising packet in accordance with the BLEwireless protocol includes information that allows other devices such asthe mobile device 12 to connect, but can also provide information abouta device. However, instead of using the data in the advertising packetfor encoding the data, e.g., encryption keys, etc., the data fortransmission is encoded according to the bit rate, symbol transmissionrate, or other type of data transmission is used. Thus, at block 304,transmitted advertising packets are encoded according to the bit rateinstead of encoding scheme identified in the packets. For example, anadvertising packet that is transmitted at 1 Mbit/s is encoded with a ‘0’value, and when transmitted at 2 Mbit/s is encoded with a ‘1’ value.Accordingly, the transmission of advertising packets is itself employedas a data hiding technique, in particular, in the exchange secret orsensitive data, encryption keys, identification, and so on.

For example, an advertising packet includes a URI type field thatidentifies a UTF-8 encoding scheme. Nevertheless, the system relies onthe bit rate to encode the data. Here, a custom BLE protocol stack maybe implemented for execution by the device with a unique profile thatmatches that on the intended connected device. This ensures that boththe host and controller operate with an aligned interface to drive andmanage the secure connection and data transfer. The pump does notconnect to any BLE device but rather communicates via a customapplication or proprietary device, e.g., controller, compatible bloodglucose meter, with compatible firmware, hardware, software, or acombination thereof, to support the connection and data communication.

Referring to FIG. 4 , in other embodiments, the medical pump 10 canoutput (402) a modulated received signal strength indicator (RSSI), or ameasurement of the power present in a radio signal expressed in dBm ordecibels relative to milliwatts of received power, in the advertisingpacket. In this embodiment, the controller 20 includes an RSSI modifyingelement that includes a signal modification module 40, for example,formed of electrical circuits and/or software that controls the signalstrength transmitted by the pump 10, e.g., the signal strength of areceived wireless signal, for example, a radio frequency (RF) signal.The mobile device 12 operating in a BLE scanning state can receiveadvertising packets from the pump 10 including an RSSI distanceestimation value. The output power is not known to the receiver 10 sothe output power information may be included in the advertising packet.The encoder 22 of the pump controller 20 can encode the data in thissignal to arbitrary bit depths, limited only by the noise in the RSSI onthe receiving device 12. For example, changing the transmit strengthfrom 0 dBM to −20 dBm can signify a ‘0’ followed by a ‘1’, or thedirection of change could itself encode a ‘0’, for example, similar to aManchester encoding format. When the mobile device 12 responds (404), ahandshake (bonding or pairing) is formed (406), facilitating a confirmedtransfer (408) of data to the mobile device 10.

FIG. 5 is a flow diagram of an embodiment of a method 500 for datahiding in a pairing between the medical pump 10 and mobile electronicdevice 12 of the medical pump system of FIGS. 1 and 2 , in accordancewith some embodiments. At least some of method 500 can be executed by anelectronic pairing device of the controller 20 that is implemented inhardware, software, firmware, or a combination thereof.

At block 502, the pump 10 employs an encoding scheme to advertisingpackets formed by the advertising packet generator 24. An advertisingpacket in accordance with the BLE wireless protocol contain informationcan include an RSSI distance estimation value. However, the data hidingprocessor 23 processes an RSSI signal altered by the signal modificationmodule 40 to provide at block 504 an encoding scheme based on the signalstrength, for example, changing the transmit strength from 0 dBM to −20dBm can signify a ‘0’ followed by a ‘1’, or the direction of changecould itself encode a ‘0’. Accordingly, the transmission of advertisingpackets is itself employed as a data hiding technique, in particular, inthe exchange secret or sensitive data, encryption keys, identification,and so on.

Referring to FIG. 6 , in other embodiments, data can be exchanged via aninductive or otherwise near field communication between a medical pump10 and a mobile device 12 such as a smartphone or the like, offering alow-power, proximity-mediated alternative to existing wirelesscommunication techniques. The medical pump 10 can include an electronicpairing device, namely, an RF near field communication device 60, whichcan be instructed and arranged to share data including secret or privatedata such as encryption keys and/or other information used to generateencryption keys. The RF near field communication device 60 can be formedof electronic circuits and/or software stored in a memory 18 andexecuted by a hardware processor 16 of the pump 10 to provide a nearfield channel between the pump 10 and the mobile device 12. In someembodiments, the RF near field communication device 60 is implemented asan inductive loop, for example, tuned to a predetermined frequency suchas 125 kHz, 13.56 MHz, and so on, but not limited thereto. In someembodiments, the RF near field communication device 60 generates anelectronic communication according to a well-known technicalstandardized protocol such as radio-frequency identification (RFID) orNFC. In other embodiments, the RF near field communication device 60communicates with the mobile device 12 in accordance with a customprotocol that is an alternative to RFID or NFC, such as a pulse-basedcommunication, Manchester-encoded information, amplitude, or frequencymodulated signals, and so on. The data hiding processor 23 applies anencoding scheme with respect to data exchanged by the RF near fieldcommunication device 60. In cases where NFC provides a data exchange, atemporary key is communicated during a pairing process, which isrequired by the BLE device. However, NFC lacks security features againsteavesdropping or the like. The NFC pairing process shown in FIG. 6 canprovide security generally lacking in NFC by including a proprietarytechnique of modulating frequency. Here, a form of inductive couplingcan occur.

To perform capacitive coupling, each of the pump 10 and the mobiledevice 12 includes a conductive electrode element, for example, a metalplate, in order to form a capacitive coupling in which the pump 10 andthe mobile device 12 communicate by modulating signals on a mutualcapacitance. A voltage source 62 can apply voltage pulses (602) to themetal plate 60 or related electrode of the pump 10, also referred to asa transmitter electrode. The mobile device 12 likewise includes acapacitive electrode 65, for example, a metal plate. In someembodiments, as shown in FIG. 6 , the mobile device electrode 65 isinternal to and part of the device 12. In other embodiments, the mobiledevice electrode 65 is removably coupled to the housing of the mobiledevice 12 to be in use only for communication with the pump 10.

When the pump 10 and mobile device 12 are positioned so that they areproximal each other, i.e., their respective electrodes 60, 65 areproximal and substantially parallel so as to permit the formation of anelectric field (F) therebetween, the mobile device 12 may receive (604)an AC coupled version of the pump-generated voltage pulses. Thesevoltage pulses (604) may be decoded by the mobile device's decoder 32into communication data.

For example, the pump controller 20 may include a pulse-width modulationmodule or other hardware and/or software that generates the signals fortransmitting data to the mobile device via the electric field (F). Thenear field communication can establish secure channels and useencryption when sending sensitive data (606), for example, between thetwo RFID or NFC-enabled devices 10, 12.

Referring to FIG. 7 , in other embodiments, a medical pump 10 caninclude one or more voice recognition sensors 70, such as a microphoneor other acoustic detector and associated processors, which may beanother type of electronic pairing device, and can be constructed andarranged to receive voice captured by the mobile device 12 and convertedinto electronic signals for output to the pump 10, and in doing so, caninstruct the pump 10 via voice commands or the like to accept a pairingrequest from the mobile device 12. In other embodiments, the data hidingtechniques described in FIGS. 3-5 can be executed by the pump 10 shownin FIG. 7 . For example, voice-related features can be added to otherforms of code exchanges or device recognition.

The pump 10 can output from a generating device 72 a keyword or phrase(702) to the mobile device 12, which is then displayed (704) on a userinterface of the mobile device. The mobile device user utters (706) thedisplayed keyword or phrase, which is detected by a voice recognitionsensor 70 of the pump 10. Upon detecting (708) that the keyword orphrase has been spoken, the pump controller 20 can determine that theuser is in sufficient proximity and has control of the device 12.

In some embodiments, the voice recognition sensor 70 recognizes theidentity of the speaker. Here, when a patient first receives the pump10, the patient may be required to participate in a training program orroutine, during which the patient utters various words or phrases sothat the pump 10 can collect sufficient data to subsequently match theuser's voice to the voice captured when speaking (706) during a pairingoperation.

Referring to FIG. 8 , in other embodiments, a medical pump 10 caninclude an electronic pairing device, namely, and audible processingdevice 80 that generates and outputs audible emissions such as tones,songs, or other audible waveforms. In some embodiments, the audibleprocessing device 80 includes a tone generator but not limited thereto.In other embodiments, the mobile device 12 includes an audible generator(not shown) instead of the medical pump 10. In other embodiments, eachof the pump 10 and the mobile device 12 includes audible device 80 and areceiver (not shown) for receiving and processing audible emissions fromthe other of the pump 10 and the mobile device 12.

In embodiments where the pump 10 controls the audible device 80 to emita sound, the pump encoder 22 encodes the sound to include data and themobile device 12 includes a decoder 32 that decodes the transmissions,for example, musical notes, rhythm, timing, frequency changes betweenadjacent notes, frequency modulation of a single note, volume, and/orother characteristic of an audible signal but not limited to. Inembodiments where the mobile device 12 generates and emits a sound, themobile device 12 includes an encoder 31 that encodes the sound toinclude data. This feature permits a user to listen to music, soothingsounds such as ocean waves, tropical rain forest, and so on while thesesounds also contribute to a pairing process between the pump 10 and themobile device 12.

In some embodiments, the audible device 80 generates acousticcommunication signals that are outside the audio frequency range thatcan be heard by the human ear, e.g., 20 Hz to 20,000 Hz. For example,the audible device 80 can include an electronic device that providesultrasonic emissions, chirps, or the like. In some embodiments, one ofthe pump 10 and the mobile device 12 can generate ultrasonic sounds, orother emissions inaudible to humans, that is received by the other ofthe pump 10 and the mobile device 12. For example, the pump 10 or mobiledevice 12 may employ a special-purpose ultrasonic receiver or capacitivepressure sensor, and the other of the pump 10 or mobile device 12employs a speaker or piezo disc or other emitter, e.g., part of audibledevice 80, for generating ultrasonic signals. Data is encoded in anaudio signal by the pump 10 transmitting a high frequency signal, e.g.,whistling a variable frequency, which can be interpreted by the intendedreceiving device 12 to provide a level of security and ensure that theappropriate devices are paired.

Referring to FIG. 9 , in other embodiments, a medical pump 10 caninclude special-purpose sensor 90 such as an accelerometer or inertialmeasurement unit as yet another type of electronic pairing device thatdetects when the pump 10 experiences an unexpected, sudden, or othermovement that is determined to be out of the ordinary. When the pump 10is in free fall or other sudden acceleration (902), e.g., the x, y, andz axes of a Cartesian coordinate arrangement) are measured by the sensor90 at 0 g values, the pump 10 can output (904) a pairing request to themobile device 12. The device 12 intended to be connected to the pump 10,e.g., a smartphone with software application when executed is in apairing mode, so that the device 12 expects to receive a confirmationfrom the pump 10 that it has be subjected to the “freefall” behavior.

Referring to FIG. 10 , in other embodiments, a medical pump 10 relies ona change in an ambient lighting condition to exchange data related to apairing operation. Here, the pump 10 can employ one or more lightsensors 100 such as reverse-biased LEDs or the like to permit the pump10 to detect when the pump 10 is enclosed or otherwise positioned in aspecial shipping package 11. For example, if the shipping package 11containing the pump 10 blocks a certain wavelength of light, then whenthe photo detector detects that wavelength of light for the first timeafter it was blocked, the pump 10 can temporarily accept pairingattempts. Although light sensors are described, other sensors thatdetect electromagnetic radiation in other sections of theelectromagnetic spectrum, i.e., other than visible light, may equallyapply.

In some embodiments, the pump 10 can store light wavelengthcharacterization data in memory 18 or to characterize at run time viaambient light analysis, the wavelength response of one or more reversebiased LEDs 100. Then, in the pairing process, the pump 10 could turn onthose LEDs 100. A camera 34 on the device 12 could be directed at theLEDs 100 to establish an electronic communication and/or other exchangeof electromagnetic signals. The device 12 could then characterize thespectrogram of light produced by the LEDs, and transmit this informationto the pump 100, thereby demonstrating that the device 12 is in closeproximity to the pump 10 at that time.

Referring to FIG. 11 , in other embodiments, the mobile device 12 caninclude hardware and/or software, for example, an accelerometer, toinstruct a user to change an orientation of the mobile device 12. Thiscan be achieved, for example, by displaying an image or otherrepresentation of the pump in desired orientations, for example,orientations determined to result in an electronic communication betweenthe pump 10 and device 12 that includes a pairing. In response, the usercan orient or otherwise move the pump 10 according to the instruction tomatch the displayed orientation of the pump. In some embodiments, thepump 10 can include an RF near field communication device, for example,shown and described with reference to FIG. 6 , and the user can orientthe pump 10 to match the displayed representation. By combining thisfeature with a near field communication means, the accelerometer datacould be sent from the pump 10 to the device 12 as part of out-of-bandpairing.

The method 1100 shown in FIG. 11 can therefore be executed by the systemshown in FIG. 6 . Other embodiments permit the method 1100 to beperformed on a medical pump system illustrated in other figures hereinthat perform a pairing operation.

At block 1102, an application stored at and executed at the mobiledevice 12 can display a series of predetermined graphics, pictures, orthe like of the pump 10 in various orientations.

At block 1104, the user can hold the pump 10 up to the mobile device 12to establish an electronic communication.

At block 1106, the pump 10 outputs accelerometer data including acurrent orientation to the mobile device 12. In some embodiments, thepump 10 outputs a current orientation as part of accelerometer data viaan NFC communication to the device 12.

At block 1108, the mobile device application validates a proper rangethat is sufficient to complete an authorization process between themobile device 12 and the pump 10. At decision diamond 1109, the method1100 may return to block 1102, where different orientation in thedisplayed series of graphics, etc. is processed until an accelerometerreading is provided from the pump 10 to the mobile device 12 for eachorientation in the displayed sequence.

At block 1110, after the entire sequence is processed and validated, themobile device 12 could output its BLE MAC ID or similar identifyingcharacteristic via an NFC communication to the pump 10, which stores itin a whitelist or other data storage arrangement.

The user may hold the pump 10 and device 12 together and randomly varythe orientation. Since both device 12 and pump 10 are experiencing thesame change in orientation, they can use an inertial measurement unit,accelerometer, or similar to record those changes and use them toindependently generate the same encryption key or seed for an encryptionalgorithm. This technique cannot be snooped on wirelessly as it is apurely physical sharing of data—both pump 10 and device 12 areexperiencing the same orientations and feeding the changes inorientation, absolute orientation, or a post-processed representation oforientation into the same algorithm. In some embodiments, the remotedevice 12 sends a signal regarding a motion, change in force, or thelike that is detected by a sensor of the remote device 12 and output tothe pump 10. The controller 20 in response processes the received signaldata and determines whether there is a match or other comparison resultto facilitate a pairing operation. In some embodiments, authorizationexchanges are made between the pump 10 and remote device 12 as part ofor instead of the operation.

Two separate encryption keys could be generated as follow. When the userwants to pair a new device, the user can choose an option on theapplication, and then bring the device, i.e., pump 10, in contact withthe remote electronic device 12 such as a mobile phone or othercompatible device such as a blood glucose meter or continuous glucosemonitoring system. The application can instruct the device that a newpairing is to be initiated by using NFC. When the LEDs flash a certaincolor pattern, the user separates the two and rotates the remoteelectronic device 12 and the pump 10 separately for a set amount of timein as many directions as possible. The more random this is, the quickerthis phase will end. The pump and phone use their respectiveaccelerometers to generate a random public key on each side and exchangethem. The pump 10 has also used the second half of the accelerometeroutputs to generate a random seed (a nonce). It will use this togenerate a Confirmation Value. At this point the pump 10 will use somepattern to tell the user to bring the pump 10 and remote electronicdevice 12 in contact.

Using NFC, the pump sends the Confirmation Value and Nonce to anapplication stored at and executed by the remote electronic device 12 orrelated device. The application then uses the Nonce to generate aConfirmation Value. Both values should match. The application then sendsits BLE MAC ID to the device to signify success, and the pump 10 addsthe MAC to its whitelist.

Referring to FIG. 12 , each of the pump 10 and remote electronic device12 has an inbuilt accelerometer or other inertial measurement unit thatcan form a pairing when the tapping or shaking actions by one or both ofthe pump 10 and remote electronic device 12, which can be simultaneouslymeasured by both the pump 10 and device 12, then used to demonstrateclose proximity and thereby identity. For example, a shaking or tappingpattern can be detected simultaneously by an accelerometer or otherinertial measurement unit that 122 built into a smartphone 120 as wellas an inertial measurement unit 110 that one in the pump 10. If the pump10 and phone 12 are in contact these patterns should be similar in phaseto confirm they are the correct devices with intention of pairingtogether. For example, the user could place the pump 10 on top of thedevice 120, which in turn is positioned on a tabletop, then tap apattern on the top of the pump 10. The particular tap timing or othercharacteristics such as duration, strength, vibration, etc., as measuredby the underlying device 120 can be sent from the device 120 to the pump10, where those characteristics could be correlated, e.g., by theaccelerator 110 of the pump 10 taking measurements for comparison tothose of the device 120, to determine whether the respective motionsenacted on the device 120 and pump cause the measured signals to be inphase, or otherwise formed to have similar signal characteristics.Tapping or shaking detected by the pump 10 could also be used toinstruct the user to confirm an intended action by the device 120instructing, for example, “double tap the pump,” followed by the pump 10confirming to the device 120 that a double tap was detected. Upon suchhandshake, an action such as changing delivery rate could be enacted.

Referring to FIG. 13 , in some embodiments the pump 10 includes anatmospheric pressure sensor 130 inside the pump 10. To confirm identityor to ask the user to confirm an intended action, a device 130 couldinstruct the user to squeeze the case. The atmospheric pressure sensor130 may be positioned in a sealed or semi-sealed case 132 for monitoringthe pressure of the ambient atmosphere. The pump's interior pressure isaffected by the user squeezing the casing or could be detected by, forexample, one or more strain gauges 134 attached to the case 132 ordeposited throughout the body of the pump. In some embodiments, thesensor 130 can detect pressure changes in the air volume of the pumpduring a dispense cycle and may also include temperature measurementcapabilities. Another example is the detection of small changes in thevalue of components such as capacitors that vary when squeezed or whenpressure changes. The pressure sensor 130 is operatively coupled to thecontroller 20 which may be configured to monitor pressure measurementsof the pressure sensor 130 from within the air volume of the fluidreservoir of the pump 10. The direction would come from a separatedevice such as a smartphone with a specific MMI application intended tocompliment the pump 10. The squeezing is intended to provide analternative method to input a passcode which is typically performed witha keypad or buttons. The passcode can include a pattern of short andlong squeezes or a certain quantity of momentary squeezes, waitingdirection from the application for an additional quantity. Predeterminedtactile forces, such as a number of squeezes, e.g., 3-5 times, may berepeated to provide the passcode.

Embodiments illustratively described herein suitably may be practiced inthe absence of any element(s) not specifically disclosed herein. Thus,for example, in each instance herein any of the terms “comprising,”“consisting essentially of,” and “consisting of” may be replaced witheither of the other two terms. The terms and expressions which have beenemployed are used as terms of description and not of limitation and useof such terms and expressions do not exclude any equivalents of thefeatures shown and described or portions thereof, and variousmodifications are possible. The term “a” or “an” can refer to one of ora plurality of the elements it modifies (e.g., “a reagent” can mean oneor more reagents) unless it is contextually clear either one of theelements or more than one of the elements is described. Thus, it shouldbe understood that although embodiments have been specifically disclosedby representative embodiments and optional features, modification andvariation of the concepts herein disclosed may be resorted to by thoseskilled in the art, and such modifications and variations are consideredwithin the scope of this disclosure.

With regard to the above detailed description, like reference numeralsused therein refer to like elements that may have the same or similardimensions, materials, and configurations. While particular forms ofembodiments have been illustrated and described, it will be apparentthat various modifications can be made without departing from the spiritand scope of the embodiments of the invention. Accordingly, it is notintended that the invention be limited by the forgoing detaileddescription.

What is claimed is:
 1. A method for wireless electronic communicationbetween a medical apparatus and a remote electronic computing device,comprising: generating and outputting by the medical apparatus an outputsignal, including encoding data in the output signal according to apredetermined characteristic of the output signal, including: outputtingat least one advertising packet from the medical apparatus to the remoteelectronic computing device; and encoding the at least one advertisingpacket according to a data transmission characteristic of thepredetermined characteristic of the output signal, the method furthercomprising: receiving and decoding by the remote electronic computingdevice encoded data of the at least one advertising packet in the outputsignal; and establishing a pairing between the medical apparatus and theremote electronic computing device in addition to transmitting deviceoutput data.
 2. The method of claim 1, wherein the medical apparatusincludes an insulin delivery pump or other medical device and the remoteelectronic computing device includes a user interface and aninput/output computing element for operating and controlling the insulindelivery pump or other medical device.
 3. The method of claim 1, whereinthe wireless electronic communication complies with at least one of aBluetooth Low Energy (BLE) wireless protocol, a near field communication(NFC) protocol, or a radio-frequency identification (RFID) protocol. 4.The method of claim 1, wherein the predetermined characteristic of theoutput signal includes a bit rate or a symbol transmission rate, and theoutput signal includes data encoded according to the bit rate or asymbol transmission rate.
 5. The method of claim 4, further comprising:varying the bit rate in a sequence that generates the code, wherein thevaried bit rate creates a pattern that is recognized by the remoteelectronic computing device and identified to represent a uniqueidentification that is acceptable for pairing.
 6. The method of claim 4,wherein the bit rate or the symbol transmission rate is processed forencoding the data instead of data in a plurality of advertising packetsincluding the at least one advertising packet exchanged between theremote electronic computing device and the medical apparatus by themedical apparatus including a processor and a memory that executes andstores, respectively, a custom Bluetooth Low Energy (BLE) stackincluding a unique profile that matches a profile stored on the remoteelectronic computing device.
 7. The method of claim 4, wherein thepredetermined characteristic of the output signal includes a signalstrength of the output signal, and the output signal includes dataencoded according to a modulated received signal strength indicator(RSSI) that is output to the remote electronic computer device.
 8. Themethod of claim 1, further comprising configuring the medical apparatusto include an electronic pairing device that processes an external eventthat changes a current state of the medical apparatus to a state thatinitiates the pairing.